Z-1652-2025 Class II Ongoing
FDA device recall Z-1652-2025 was initiated by Abbott Laboratories on March 18, 2025 and is designated Class II. Reason for recall: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired… The recall status is ongoing. Affected quantity: 2947.
Recall Details
- Product Type
- Devices
- Report Date
- April 30, 2025
- Initiation Date
- March 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2947
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY and OUS (foreign) to countries of: Afghanistan, Albania, Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Croatia, Czech Rebublic, Ecuador, Egypt, El Salvador, Ethiopia, France, Gambia, Gaza & Jericho, Germany, Greece, Guatemala, Guana, Haiti, Honduras, Hong King, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, New Caledonia, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, St. Lucia, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turk & Caicos, Turkey, UAE, Uganda, UK, Ukraine, Uruguay, Uzbekistan, Vietnam, and Yemen.